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TOPLINE:

Adjunctive home-based low-field magnetic stimulation (LFMS) was associated with significantly improved self-rated depression scores, but not clinician-rated scores, compared with sham stimulation in patients with bipolar depression, a new study showed.

METHODOLOGY:

• A randomized, double-blind, sham-controlled trial conducted from 2018 to 2020 included 60 patients aged 18-60 years (mean age, 28 years; 51% male) from China with bipolar depression.
• Patients were randomly assigned 1:1 to receive adjunctive active LFMS or sham stimulation. Both were administered twice daily at home for 20 minutes per session over 2 weeks, totaling 28 sessions.
• All participants maintained stable-dose lithium carbonate throughout the 6-week study period. The final analysis included 24 patients in the LFMS group and 27 in the sham stimulation group.
• The primary outcome was the total change score from baseline to 6 weeks on the clinician-rated Hamilton Depression Rating Scale-17 (HAMD-17). Secondary outcomes included changes in baseline scores on the Hamilton Anxiety Rating Scale (HAMA) and on the self-reported 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) and the seven-item Generalized Anxiety Disorder (GAD-7) scale at weeks 1, 2, 4, and 6; adverse events; and switch rates, defined as an emergence of mania, hypomania, or rapid cycling.

TAKEAWAY:

• Both groups showed rapid improvement on all measures, but there were no significant between-group differences on the HAMD-17, HAMA, or GAD-7 at any timepoint.
• Active LFMS was associated with significant improvement in self-reported depression on the QIDS-SR16 at week 4 (difference, 1.79; P = .03) and week 6 (difference, 1.83; P = .02) compared with sham stimulation.
• Mood switch events occurred in one member of each group, and no severe treatment-related adverse events were observed. There were two cases of mild headache in the active stimulation group assessed as possibly related to the intervention and one case of nausea related to lithium in the sham group.

IN PRACTICE:

The investigators noted that this was the first randomized trial to evaluate home-based LFMS for bipolar depression and showed that the intervention was “feasible, safe, and well tolerated,” while highlighting the importance of subjective endpoints.

The study results also “offer rigorous evidence to refine future neuromodulation strategies, suggesting that longer treatment durations, optimized stimulation parameters, or multidimensional outcome assessments may be necessary to achieve robust clinical efficacy in bipolar depression,” they added.

SOURCE:

The study was led by Jiamiao Wu, MD, National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China. It was published online on May 26 in the Journal of Affective Disorders.

LIMITATIONS:

The randomization of the study sample led to lower baseline anxiety scores and higher BMI in the LFMS group than in the sham stimulation group. The study restricted adjunctive therapy to lithium carbonate, limiting generalizability to patients on other mood stabilizers or complex polypharmacy regimens.

DISCLOSURES:

The study was funded by the National Natural Science Foundation of China. The investigators reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.